Pirfenidone
- Generic Name
- Pirfenidone
- Brand Names
- Esbriet, Pirfenidone axunio (previously Pirfenidone AET), Pirfenidone Viatris
- Drug Type
- Small Molecule
- Chemical Formula
- C12H11NO
- CAS Number
- 53179-13-8
- Unique Ingredient Identifier
- D7NLD2JX7U
- Background
Pirfenidone is a synthetic pyridone drug. It is an antifibrotic agent with anti-inflammatory and antioxidant properties that is used to treat idiopathic pulmonary fibrosis (IPF), which is a chronic, progressive form of interstitial pneumonia. While its mechanism of action is not yet fully understood, pirfenidone is proposed to primarily regulate tumor necrosis factor (TNF) pathways and modulate cellular oxidation. The FDA first approved pirfenidone alongside nintedanib as one of the first drugs to treat IPF.
- Indication
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). In Canada and Europe, it is approved in adults only.
- Associated Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Mild Idiopathic Pulmonary Fibrosis, Moderate Idiopathic Pulmonary Fibrosis
Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
- First Posted Date
- 2017-07-06
- Last Posted Date
- 2020-11-20
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 60
- Registration Number
- NCT03208933
- Locations
- 🇷🇺
Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology, Barnaul, Altaj, Russian Federation
🇷🇺Pulmonologii NII FMBA of Russia, Moscow, Moskovskaja Oblast, Russian Federation
🇷🇺Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1", Voronezh, Russian Federation
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
- Conditions
- Metastatic Lung CancerNon Small Cell Lung CancerAdvanced CancerSquamous Cell Lung CancerNon-Squamous Non-Small Cell Neoplasm of LungLung Cancer
- Interventions
- First Posted Date
- 2017-06-06
- Last Posted Date
- 2025-05-20
- Target Recruit Count
- 48
- Registration Number
- NCT03177291
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Quality of Life Study in Participants With IPF Under Pirfenidone Treatment
- First Posted Date
- 2017-04-14
- Last Posted Date
- 2020-08-21
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 102
- Registration Number
- NCT03115619
- Locations
- 🇬🇷
University General Hospital of Ioannina, Ioannina, Greece
🇬🇷Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology, Athens, Greece
🇬🇷University General Hospital of Athens "Attikon", B' University Pulmonary Clinic, Chaidari, Greece
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
- Conditions
- Multiple Sclerosis
- Interventions
- First Posted Date
- 2017-04-12
- Last Posted Date
- 2025-04-27
- Target Recruit Count
- 250
- Registration Number
- NCT03109288
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2021-01-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 253
- Registration Number
- NCT03099187
- Locations
- 🇦🇺
John Hunter Hospital; Respiratory Department; Respiratory Department, New Lambton Heights, New South Wales, Australia
🇦🇺Lung Research Queensland, Nundah, Queensland, Australia
🇦🇺Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine, Woolloongabba, Queensland, Australia
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- First Posted Date
- 2017-03-01
- Last Posted Date
- 2017-03-01
- Lead Sponsor
- RenJi Hospital
- Target Recruit Count
- 72
- Registration Number
- NCT03068234
- Locations
- 🇨🇳
RenJi Hospital, Shanghai, Shanghai, China
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
- First Posted Date
- 2017-02-08
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 21
- Registration Number
- NCT03047031
- Locations
- 🇮🇳
P.D. Hinduja National Hospital, Mumbai, India
🇮🇳Asthma Bhawan, Jaipur, India
🇮🇳CK Birla Hospitals, The Calcutta Medical Research Institute, Kolkata, India
Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
- Conditions
- Interstitial Lung Disease
- Interventions
- Other: Placebo controlled
- First Posted Date
- 2016-11-08
- Last Posted Date
- 2023-01-09
- Lead Sponsor
- Evans Fernandez Perez
- Target Recruit Count
- 40
- Registration Number
- NCT02958917
- Locations
- 🇺🇸
National Jewish Health, Denver, Colorado, United States
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- First Posted Date
- 2016-11-01
- Last Posted Date
- 2020-11-12
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 177
- Registration Number
- NCT02951429
- Locations
- 🇳🇱
Vu Medisch Centrum; Afdeling Longziekten, Amsterdam, Netherlands
🇹🇷Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari, Istanbul, Turkey
🇿🇦University of Stellenbosch; Respiratory Research, Parow, South Africa
The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
- First Posted Date
- 2016-10-13
- Last Posted Date
- 2020-07-02
- Lead Sponsor
- Manchester University NHS Foundation Trust
- Target Recruit Count
- 129
- Registration Number
- NCT02932566
- Locations
- 🇬🇧
Manchester University NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
Drug Development Updates
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